PURPOSE: This rule establishes requirements for utilizing an electronic data processing system in a pharmacy.

1. (1) All information concerning the compounding, dispensing or selling at retail of any drug, medicine or poison pursuant to a lawful prescription which is entered into an electronic data processing (EDP) system at any pharmacy shall be entered only by a licensed pharmacist or by an individual under the direct supervision and review of a licensed pharmacist. That pharmacist shall be personally responsible for the accuracy of the information.

2. (2) Any EDP system used by any pharmacy for record keeping shall comply with the requirements of section 338.100, RSMo, including the capability to store and retrieve the following information concerning the filling or refilling of any prescription:

   1. (A) A prescription label number that is linked to the unique readily retrievable identifier;
   2. (B) Date of original prescription, expiration date of the prescription or both;
   3. (C) Date original prescription was filled;
   4. (D) Patient’s full name;
   5. (E) Patient’s address when a prescription prescribes a controlled substance;
   6. (F) Prescriber’s full name;
   7. (G) Prescriber’s address and Drug En - force ment Administration (DEA) number when a prescription specifies a controlled substance;
   8. (H) Name of drug, medicine or poison dispensed;
   9. (I) Quantity of drug, medicine or poison originally dispensed;
   10. (J) Quantity of drug, medicine or poison dispensed on each refill;
   11. (K) Initials or code of the pharmacist responsible for input or review of data on each original prescription and each refill;
   12. (L) Date of each refill; and
   13. (M) If a new prescription is transmitted by phone, a hard copy representation must be made and contain all of the information in subsections (2)(A)–(L) plus an indication of whether or not a generic substitution is permitted and made in accordance with 4 CSR 220-3.011.
3. (3) Prescription hard copies must be filed by either the prescription label number or by the unique readily retrievable identifier. Prescription hard copies must be retrievable at the time of inspection.

4. (4) Any pharmacy using an EDP system as described in section (1) shall provide documentation that the information concerning the refills of prescriptions entered into the system for all prescription drugs is accurate. This documentation shall include:

   1. (A) The initials or code designation of the dispensing pharmacist for each refill;
   2. (B) The date of the refill;
   3. (C) The quantity of substances refilled;
   4. (D) The number of authorized refills or dispensable units remaining;
   5. (E) If additional refills are authorized and added to an existing prescription, a notation indicating the method and source of the authorization must be a part of the EDP record or hard copy, in that case the expiration date of the original prescription shall remain the same; and
   6. (F) If any other alteration is made in the original prescription record, a clear audit trail must be maintained. This shall include, but is not limited to, a change in authorizing physician, a change in total quantity ordered or a change in directions.

5. (5) Any pharmacy using an EDP system as described in section (1) shall maintain the following:

   1. (A) A bound logbook or separate file in which each pharmacist involved in the pharmacy’s record keeping system shall sign a statement each day attesting that information concerning the refill of prescriptions has been entered into the system for that day and that the pharmacist has reviewed the information for accuracy. The logbook or file shall be maintained at the pharmacy for at least five
6. (5) years after the date the drugs, medicines or poisons are dispensed.
7. (6) Any hospital pharmacy using an EDP system, as described in section (1), for outpatient prescriptions, employee prescriptions and take-home prescriptions shall conform to all sections of this rule.
8. (7) Any EDP system, as described in section (1), must be capable of producing the record required in subsections (2)(A)–(M) and said records shall be readily retrievable on-line. Readily retrievable is defined as providing EDP records within two (2) hours of time of request by an inspector or by making a computer terminal available to the inspector for immediate use.
9. (8) An auxiliary record keeping system shall be established for the documentation of refills if the EDP system is inoperative for any reason. The auxiliary system shall insure that all refills are authorized by the original prescription or prescriber. When this EDP system is restored to operation, the information regarding prescriptions filled and refilled during the inoperative period shall be entered into the EDP system within seven (7) working days. However, nothing in this section shall preclude the pharmacist from using his/her professional judgment for the benefit of a patient’s health and safety.
10. (9) If a prescription is transferred from a pharmacy using an EDP system, a notation or deactivation must be made on the transferred record to preclude any further dispensing. If the same prescription is transferred back into the original pharmacy, it shall be treated as a new record, showing the original date written and expiration date.
11. (10) Prior to or simultaneously with the purging of any EDP system, the pharmacist-incharge or permit holder shall make certain that a record of all prescription activity being erased exists in readable form, either on paper, microfiche or electronic media storage. A pharmacy that desires to discard hard copy prescriptions that are more than three
12. (3) years old must maintain all prescription information on microfiche or electronic media. Any process utilizing microfiche must ensure that all data is available and in readable form. Any pharmacy opting for the utilization of microfiche records must also maintain a microfiche reader so that records may be reviewed on-site by pharmacy personnel or board inspectors. Electronic media storage is defined as any medium such as a computer, floppy disk or diskette, compact disk (CD) or other electronic device that can reproduce all prescription information as required by section 338.100, RSMo and this rule and is retrievable within three (3) working days.
13. (11) If coded information exists in the electronic EDP, the board inspector may request the definitions of the codes from the pharmacist on duty for immediate review.
14. (12) The EDP system shall be able to provide a listing of drug utilization for any drug for a minimum of the preceding twelve (12)-month period. Drug utilization information shall be available by specific drug product, patient name or practitioner. If requested to do so, the pharmacy shall have three (3) working days to provide the report.
15. (13) The provisions of this rule shall not conflict with any federal laws or regulations. If any part of this rule is declared invalid by a court of law, that declaration shall not affect the other parts of the rule.

AUTHORITY: sections 338.100, 338.140 and 338.280, RSMo 2000.* This rule originally filed as 4 CSR 220-2.080. Original rule filed March 8, 1984, effective Aug. 11, 1984. Amended: Filed Nov. 4, 1985, effective Feb. 24, 1986. Rescinded and readopted: Filed Dec. 5, 1988, effective March 11, 1989. Amended: Filed March 15, 2000, effective Sept. 30, 2000. Amended: Filed Nov. 1, 2000, effective June 30, 2001. Moved to 20 CSR 2220-2.080, effective Aug. 28, 2006. 20 CSR 2220-2

*Original authority: 338.100, RSMo 1939, amended 1971, 1990, 1997, 1999; 338.140, RSMo 1939, amended 1981, 1989, 1997; and 338.280, RSMo 1951, amended 1971, 1981.